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Communication Skills vs. Mindfulness for IPV

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ClinicalTrials.gov Identifier: NCT03672942
Recruitment Status : Not yet recruiting
First Posted : September 17, 2018
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Julia C. Babcock, University of Houston

Tracking Information
First Submitted Date  ICMJE August 7, 2018
First Posted Date  ICMJE September 17, 2018
Last Update Posted Date April 18, 2019
Estimated Study Start Date  ICMJE September 15, 2019
Estimated Primary Completion Date September 15, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2018)
  • Observed aggression [ Time Frame: 10 minutes: Change in observed behavior/emotion from first to second conflict discussion ]
    Specific Affect Coding System (SPAFF; Gottman, McCoy, Coan, Collier, 1996). SPAFF categorizes 16 emotions based on facial affect, vocal tone, body language, and content of speech.
  • TAPS aggression paradigm [ Time Frame: 10 minutes: Change in aggression from first to second conflict discussion ]
    Overt aggression will be assessed using a modified version of the Taylor Aggression Paradigm (TAP; Epstein & Taylor, 1967). The TAP is an established method to study aggression in the laboratory. It is a deceptive, competitive reaction time task in which the participant competes against an "opponent" which is actually the computer program.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03672942 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Communication Skills vs. Mindfulness for IPV
Official Title  ICMJE A Proximal Change Experiment: Testing the Effects of Communication Skills Training vs. Mindfulness Techniques on Intimate Partner Aggression
Brief Summary This tests the immediate impact of two brief interventions on couples reporting intimate partner violence using the proximal change experimental design. Couples will be randomly assigned to a mindfulness conditions, a communication exercise or a placebo condition. Outcome measures include observed and experimentally assessed aggression.
Detailed Description This pilot study is designed to test the effects of two brief interventions on communication and emotional expression between intimate partners who have experienced recent domestic violence. In addition, it will provide some basic laboratory findings on differences in distress tolerance between perpetrators and victims of domestic abuse. Specifically, using the proximal change experimental design, couples will engaged in a 7.5 minute conflict discussion while being videotaped and having their autonomic responding monitored. Then they will be randomly assigned to one of three conditions: a communication skills training exercise, a mindfulness condition, or a placebo control. Next, ,couples will engaged in second 7.5 minute conflict discussion. It is hypothesized that those in both the communication skills training and mindfulness condition will display more positive and less aggressive behavior in their second conflict discussion as compared to their first. It is also expected that they will administer less aggression (as measured by delivery of a loud noise) to their partner after both of the active interventions. In addition, multiple measures of distress tolerance will be administered to both partners. It is expected that couples with a characterologically violent perpetrator, he or she will evidence decreased distress tolerance and the victimized partner will evidence increased distress tolerance
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
random assignment to two active conditions vs. a placebo control
Masking: Single (Participant)
Masking Description:
couples are not informed as to what condition they are assigned
Primary Purpose: Basic Science
Condition  ICMJE
  • Domestic Violence
  • Domestic Abuse
  • Family Conflict
  • Aggression
Intervention  ICMJE
  • Behavioral: Communication Skills Training
    Gentle start-up is one treatment technique in the Creating Healthy Relationship Program written by John Gottman, Ph.D.
    Other Name: Gentle Start-up
  • Behavioral: Mindfulness
    Acceptance/willingness of unwanted emotions is treatment technique of Achieving Change through Value-Based Behavior (ACTV) written by Amie Zarling, Ph.D.
    Other Name: Acceptance/Willingness of unwanted emotions
  • Behavioral: Placebo
    Couples randomly assigned to this condition listen to music on headphones. This may be considered an active placebo as it is similar to a Time Out technique taught in battering interventions.
    Other Name: Time Out Condition
Study Arms  ICMJE
  • Experimental: Communication Skills
    Male and female participants will listen to a description of John Gottman's Gentle Start-up communication skills training exercise and practice the technique in the lab for approximately 8 minutes.
    Intervention: Behavioral: Communication Skills Training
  • Experimental: Mindfulness
    Male and female participants will listen to a script about Acceptance/Willingness of unwanted emotions written by Amie Zarling and practice this technique in the lab for approximately 8 minutes.
    Intervention: Behavioral: Mindfulness
  • Placebo Comparator: Placebo
    Male and female participants will listen to music in lieu for 8 minutes.
    Intervention: Behavioral: Placebo
Publications * Babcock JC, Graham K, Canady B, Ross JM. A proximal change experiment testing two communication exercises with intimate partner violent men. Behav Ther. 2011 Jun;42(2):336-47. doi: 10.1016/j.beth.2010.08.010. Epub 2011 Feb 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 12, 2018)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 15, 2022
Estimated Primary Completion Date September 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Adult co-habituating couples Reporting some violence in the past year (score > 0 on CTS2 physical abuse subscale)

Exclusion Criteria:

Homosexual couples Children under 18 non-English speakers

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Alicia Vargas 713-743-9215 avargas5@central.uh.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03672942
Other Study ID Numbers  ICMJE STUDY00000975
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Deidentified data will be shared in a data bank.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Data requests will be reviewed by a Data Panel Review Board
Responsible Party Julia C. Babcock, University of Houston
Study Sponsor  ICMJE University of Houston
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Julia C Babcock, Ph.D. University of Houston
PRS Account University of Houston
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP